Triathlon 5537-G-716Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327027495), received between Sep 12, 2017 and May 28, 2025 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: "SUBJECT WAS ENROLLED IN THE 76-TRIATHLON® CONES AUGMENT STUDY (REVISION STUDY) ON (B)(6) 2018; SUBJECT HAD A DRAINING WOUND HEMATOMA AND ARTHROFIBROSIS (ROM-0-60°) AND WENT TO OR ON (B)(6) 2018 FOR AND I/D AND MUA. ALL AVAILABLE INFORMATION FROM THE FACILITY IS PROVIDED."

  Patient problems: Fibrosis; Hematoma

  MAUDE report 22095657 ↗
• InjurySep 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT 2 STAGE EXCHANGE FOLLOWING PRIMARY TKA IN 2013. PATIENT HAD SEPTIC SEPSIS AND UNDERWENT A 2 STAGE EXCHANGE OVER THE COURSE OF 4 MONTHS IN (B)(6) 2016 DUE TO OTHER HEALTH ISSUE. REPORTED IN Q4_2016. NOW 6 MONTHS LATER IS REVISED AGAIN FOR PROSTHETIC JOINT INFECTION WITH ONLY POLY EXCHANGE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6858778 ↗